| CTRI Number |
CTRI/2025/08/093888 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nurse led comprehensive Palliative care] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Impact of Nurse-Led Comprehensive Palliative Care on Physical and Psychological Well-being in Patients with Advanced Cancer |
|
Scientific Title of Study
|
Effectiveness of Nurse- Led Comprehensive Palliative Care Intervention on Physiological and Psychological Outcomes among patients with Advanced Cancer in a selected Hospital at Mangaluru |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pavithra K |
| Designation |
P.hd Scholar |
| Affiliation |
Yenepoya Deemed to be University |
| Address |
Assistant Professor
Department of Nursing Foundation, 5th Floor
Yenepoya Nursing College
Naringana, Deralakatte, Manglore
Assistant Professor
Department of Nursing Foundation, 5th Floor
Yenepoya Nursing College
Naringana, Deralakatte, Manglore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8722095948 |
| Fax |
|
| Email |
pavithrak@yenepoya.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Leena KC |
| Designation |
Dean/Principal |
| Affiliation |
Yenepoya Deemed to be University |
| Address |
4th Floor
Yenepoya Nursing College
Naringana, Deralakatte, Manglore
4th Floor
Yenepoya Nursing College
Naringana, Deralakatte, Manglore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8722095948 |
| Fax |
|
| Email |
leenakc@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Pavithra K |
| Designation |
P.hd Scholar |
| Affiliation |
Yenepoya Deemed to be University |
| Address |
Assistant Professor,
Department of Nursing Foundation
5th Floor
Yenepoya Nursing College
Naringana, Deralakatte, Manglore
Assistant Professor,
Department of Nursing Foundation
5th Floor
Yenepoya Nursing College
Naringana, Deralakatte, Manglore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8722095948 |
| Fax |
|
| Email |
pavithrak@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| Funding : Self Funded
Hospital : Yenepoya Medical College Hospital,
Deralakatte, Mangalore |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amar Rao |
Yenepoya Medical college Hospital |
7th Floor
Department of Oncology
Medical/Surgical Division
University Road, Mangalore
Dakshina Kannada
KARNATAKA |
9663368019
htar007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya ethics committee -2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nurse led palliative care |
physical (Stretching exercise and Education on management of physical symptoms and diet), psychological (Cognitive Restructuring and Deep breathing exercises), Social (communication and supportive information) and Spiritual (Spiritual guided meditation) |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with a tumor treated under medical or surgical or radiation oncology
Patients attending selected tertiary care hospital with the cancer or recurrence of cancer
Patients with cancer of Head and Neck cancer, GI Cancer, Lung cancer, Reproductive cancer, Breast Cancer and Gynecological cancer.
Patient with stage 3 and 4 cancer.
|
|
| ExclusionCriteria |
| Details |
Patients with Soft tissue sarcoma, Lymphoma, Leukemia, Myeloma, Brain and spinal cord cancer.
Psychiatric problems and receiving treatment
Patients admitted in intensive care unit
Patients planned for or after organ or Bone marrow transplantation.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Physiological variabes- Pain, Symptom burden, Sleep and fatigue
Psychological - Quality of life, Depression, Anxiety, Coping
|
1 month, 3 month and 5 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Palliative care is an approach that
improves the quality of life of patients (adults and children) and their
families who are facing problems associated with life-threatening illness. It
prevents and relieves suffering through the early identification, correct
assessment and treatment of pain and other problems, whether physical,
psychosocial or spiritual. Nurse-led palliative care intervention,
characterized by comprehensive, personalized, dynamic adjustment and enhanced
patient education, is significantly superior to routine care. It
comprehensively covers the physical, psychological, social and spiritual
aspects to ensure that patients receive comprehensive care. The aim of this
study is to assess the Effectiveness
of Nurse- Led Comprehensive Palliative Care Intervention on Physiological and
Psychological Outcomes among Patients with Advanced Cancer. The data will be
collected from 140 participants with advanced cancer. Stratified Block
randomization sampling will be adopted to select the participants to control
and Intervention Groups. Pre-test will be conducted for control and Intervention
Groups, followed by Intervention Group will receive Nurse-Led palliative care
intervention. Post Test will be conducted at 1 month, 3 month and 5th month.
The collected data will be analyzed using descriptive and Inferential
Statistics.
|